The onset of the COVID-19 pandemic brought unprecedented disruption to drug development.
While sponsors rushed to reallocate resources to develop treatments and vaccines, many faced challenges associated with travel restrictions, site closures, self-isolation protocols, emerging regulatory guidance, and an understandably fearful and reluctant patient population.
Such factors inevitably forced many sponsors to rethink research-and-development pipelines, sending tremors through the sector and compromising the potential for future breakthroughs across multiple therapeutic areas.
The immediate aftermath of the pandemic’s onset resulted in disruption, delay and termination of drug trials, both planned and underway. Yet as the curve flattens and restrictions relax around the world, strategies for reopening that prioritize business continuity are beginning to take shape.
With the pandemic loosening its grip on drug development, it’s time to consider the longer-term effects that COVID-19 will have on how clinical trials and supporting supply chains adapt to industry’s “new normal.” For sponsors, that term promises a time of continued disruption and heightened risk.
A recent survey of industry stakeholders highlighted concerns about the impact of COVID-19 on clinical trials. Feedback from respondents including executives, regulators, policy experts and venture capitalists pointed to an already severe impact on clinical development programs, which is expected to be broad and long-lasting.
Until vaccines and treatments are developed, approved and available globally, and COVID-19 eradicated, sponsors will need to contend with the constant threat of the virus affecting studies’ statistical viability.
Looking to the future, cash flow and financing issues are also likely to become commonplace for smaller biotech companies. They will require additional funding, despite lower stock prices and less-than-optimal market conditions. Acquisitions could become an added risk for some sponsors, while delays in launch timelines will run up against shorter periods of patent exclusivity, hindering the potential for return on investment.
However, where there’s heightened risk, there’s also heightened opportunity. For sponsors keen to maintain competitive advantage, embracing speed and precision in clinical trial operations will be key to success. One opportunity, which can enable expedited study startups and flexible, patient-centric supply, can be found in just-in-time manufacturing (JTM).
JTM offers sponsors a mechanism to safeguard continuous patient supply while simultaneously reducing product waste. It has also been shown to accelerate study startups, helping sponsors to meet increasingly aggressive timelines for post-pandemic drug development.
Standard batch manufacturing, in which supplies are made, packaged and labelled before being added to inventory to meet fixed demand, delivers some benefits for many supply scenarios. However, the need to operate with increased agility in the aftermath of COVID-19 may necessitate a move toward more adaptive methods.
As sponsors look to restart clinical trial activity — and play an epic game of catch-up in the process — they’ll need to ensure that supply chains are able to operate with the flexibility this new era of industry demands.
For example, sponsors looking to expedite study startups in order to dose patients more quickly will likely struggle to meet ambitious timeline objectives using batch methods. They might also experience costly rework and product waste through an inability to quickly effect label change. Considering the likely increase in regulatory updates, protocol amendments and deviations, this alone could present a significant challenge.
In the early stages of a study, especially where enrolment projections are uncertain, the decision to make product in bulk for “just-in-case” demand is a gamble. A “one-size-fits-all” approach to dosing magnifies the risk of waste and inefficiency. Not only do multi-country booklet labels increase timelines, they can hinder site- or patient-centric operations. This can lead to misuse of medication, negative patient experience, and retention issues. Additionally, standardized kit configurations, where patients only use what’s prescribed to them and leave the rest, create further product waste, magnifying inefficiencies and chipping away at ROI.
By contrast, JTM is designed to eliminate waste from core clinical supply processes through the full, late-stage customization of clinical kits. Whether used in isolation or as part of a wider Lean initiative, JTM helps sponsors to respond quickly to shifting demand, while preserving drug product. Sponsors utilizing such an approach make it possible for stock materials such as bottles, wallet cards, vials, ampules and prefilled syringes to be packaged and labelled just prior to shipment. That allows producers to meet varying global need, once demand is known. A JTM approach is particularly effective for programs involving personalized medicines, high-value or short-stability drugs, trials experiencing enrolment challenges, drug availability issues, and studies utilizing pooled supply strategies across multiple protocols.
The full late-stage customization of clinical supplies supports variable demand and patient-specific requirements, while mitigating the risk of exceeding expiration dates prior to distribution. This approach also removes the need to pre-package supplies before a study commences, which can contribute to faster study startup. Sponsors can expect to reduce average startup time by 50% for initial supplies, and up to 60% for new or reconfigured timelines, caused by the addition of new countries or kit types.
Furthermore, the inherent flexibility of JTM enables sponsors to respond to shifting regulatory requirements, quickly amend label texts and expiration dates, and eliminate waste and inefficiency. JTM allows sponsors to enhance patient centricity by configuring kits to meet a particular patient’s needs, from weight-based dosing to single-language labels. The technique can form the basis of an effective recruitment and retention strategy in the months and years following COVID-19.
As the dust settles on the initial outbreak phase of the pandemic, a number of key challenges will make the task of delivering the right drug to the right patient at the right time, while limiting waste, infinitely more complex and risk-intensive. The aftershocks of COVID-19 will undoubtedly have a profound effect on sponsors and their ability to sustain clinical trial operations, meet key milestones, maintain commercial performance, and advance human health. Yet opportunity exists for sponsors willing to break with tradition in favor of agile, demand-led supply strategies.
As the drug-development sector emerges from the rubble of COVID-19, sponsors must rebuild accordingly. It becomes vital for them to adopt proactive and collaborative planning and execution, to mitigate the difficulties of managing supply and demand for clinical trials in a post-pandemic landscape. They will need to embrace new strategies that facilitate fast study startup and optimized drug supply. Failure to seize the opportunity for creating safe and agile supply strategies, in a highly competitive and potentially hostile market, will make success all the more difficult to achieve.
Natalie Balanovsky is just-in-time manufacturing solutions manager at Almac Clinical Services.
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